Drug Detail:Emtriva (Emtricitabine [ em-trye-sye-ta-been ])
Generic Name: EMTRICITABINE 200mg
Dosage Form: capsule, oral solution
Drug Class: Nucleoside reverse transcriptase inhibitors (NRTIs)
Drug Detail:Emtriva (Emtricitabine [ em-trye-sye-ta-been ])
Generic Name: EMTRICITABINE 200mg
Dosage Form: capsule, oral solution
Drug Class: Nucleoside reverse transcriptase inhibitors (NRTIs)
Prior to or when initiating EMTRIVA, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].
EMTRIVA is taken by mouth once daily and may be taken without regard to food [see Clinical Pharmacology (12.3)].
EMTRIVA capsules: One 200 mg capsule administered once daily orally.
EMTRIVA oral solution: 240 mg (24 mL) administered once daily orally.
EMTRIVA oral solution: 3 mg per kg administered once daily orally.
EMTRIVA oral solution: 6 mg per kg up to a maximum of 240 mg (24 mL) administered once daily orally.
EMTRIVA capsules: For pediatric patients weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.
Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of dose adjustment recommendations in patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.4), Use in Specific Populations (8.6)].
Creatinine Clearance (mL/min) | ||||
---|---|---|---|---|
Formulation | ≥50 mL/min | 30–49 mL/min | 15–29 mL/min | <15 mL/min or on hemodialysis* |
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Capsule (200 mg) |
200 mg every 24 hours | 200 mg every 48 hours | 200 mg every 72 hours | 200 mg every 96 hours |
Oral Solution (10 mg/mL) |
240 mg every 24 hours (24 mL) |
120 mg every 24 hours (12 mL) |
80 mg every 24 hours (8 mL) |
60 mg every 24 hours (6 mL) |
There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.